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Freeze dried Lansoprazole sodium injection and its prepn process

A lansoprazole sodium and freeze-drying technology, which is applied in freeze-drying transportation, digestive system, powder transportation, etc., can solve the problems of increased pharmaceutical costs, difficult quality control, complicated process, etc., and achieve good chemical stability and easy operation , low-cost effect

Inactive Publication Date: 2006-08-02
JINZHOU JIUTAI PHARML CHINA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The publication number is " CN1660092A " Chinese invention patent application open specification has mentioned " injection lansoprazole sodium preparation and preparation method thereof ", and it is made of lansoprazole sodium, excipient, PH regulator and antibacterial Oxidants are formulated, and the cost of pharmaceuticals increases due to the addition of pH regulators and antioxidants, and the process is complicated and the quality is difficult to control

Method used

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  • Freeze dried Lansoprazole sodium injection and its prepn process

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Effect test

Embodiment 1

[0020] Get lansoprazole sodium 15~30g and excipient 5~50g, described excipient is mannitol or meglumine, and lansoprazole sodium is dissolved in 200-400ml water for injection, and excipient Dissolve in 100-300ml of water for injection; combine the above two solutions, add water for injection to 2000ml-3000ml; add 0.5-1.5g of activated carbon for decolorization, filter the filtrate through a microporous membrane, fill in a vial; freeze under sterile conditions Dry, pre-freeze at -40~-45°C for 4~6 hours, then sublime for 28~36 hours, increase the temperature by 1~2°C per hour, to 35~45°C; out of the box, cover, that is, Lansoprazole Sodium lyophilized injection.

Embodiment 2

[0022] Get lansoprazole sodium 15g and excipient 50g, described excipient is mannitol or meglumine, lansoprazole sodium is dissolved in 200ml water for injection, and excipient is dissolved in 300ml water for injection ; Combine the above two solutions, add water for injection to 2000ml; add 0.5g of activated carbon for decolorization, filter the filtrate through a microporous membrane, fill in a vial; freeze-dry under sterile conditions, pre-freeze at -40~-45℃ for 4~ 6 hours, sublimated for 28 to 36 hours, and raised the temperature by 1 to 2 °C per hour to 35 to 45 °C; out of the box, capped, and the lyophilized injection of Lansoprazole Sodium was obtained.

Embodiment 3

[0024] Get lansoprazole sodium 30g and excipient 5g, described excipient is mannitol or meglumine, lansoprazole sodium is dissolved in 400ml water for injection, and excipient is dissolved in 100ml water for injection ; combine the above two solutions, add water for injection to 3000ml; add 1.5g of activated carbon for decolorization, filter the filtrate through a microporous membrane, fill in a vial; freeze-dry under sterile conditions, pre-freeze at -40~-45℃ for 4~ 6 hours, sublimated for 28 to 36 hours, and raised the temperature by 1 to 2 °C per hour to 35 to 45 °C; out of the box, capped, and the lyophilized injection of Lansoprazole Sodium was obtained.

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Abstract

The freeze dried Lansoprazole sodium sdinjection has Lansoprazole sodium as active component and mannitol or meglumine as excipient in the weight ratio of 15-30 g to 5-50 g. The preparation process of the freeze dried Lansoprazole sodium injection includes the following steps: dissolving Lansoprazole sodium in 15-30 g in injection water of 200-400 ml, dissolving mannitol or meglumine as excipient in 5-50 g in injection water of 100-300 ml, mixing the two kinds of obtained solutions and adding injection water to 2000-3000 ml, adding active carbon in 0.5-1.5 g, filtering with microporous filter membrane, packing in vial, freeze drying under bacteria-free condition, and pressing cap. The freeze dried Lansoprazole sodium injection is used clinically in intravenous drip or intramuscular injection to treat peptic ulcer and other diseases.

Description

technical field [0001] The invention relates to a medicine with anti-peptic ulcer, in particular to a lansoprazole sodium freeze-dried injection and a preparation method thereof. Background technique [0002] Lansoprazole sodium is a C 16 h 13 f 3 N 3 NaO 2 The benzimidazole compound of S has a molecular weight of 391.34 and has the following chemical structure: [0003] [0004] Its chemical name is: 2-{[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridine]methyl]sulfinyl}-1H-benzimidazole sodium. [0005] Lansoprazole is a proton pump inhibitor, suitable for gastric ulcer, duodenal ulcer, reflux esophagitis, and Zoller-Ehrlich syndrome. [0006] Because lansoprazole is insoluble in water, brings a lot of inconvenience to preparation, and stability is also relatively poor, and it is made into sodium salt, then can change its solubility in water, and chemical stability also has greater improvement. Lansoprazole sodium is easily soluble in water, and it is made into freez...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K9/19A61P1/04
Inventor 李志清王亚琴杜桂杰马学良
Owner JINZHOU JIUTAI PHARML CHINA
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